A fantastic perspective publication by Pablialunga et al " The impact of N-nitrosamine impurities on clinical drug development"
I found pretty interesting some reflection the author offer on the overall impact of Nitrosamine Impurities:
- Emerging of Nitrosamine Impurities have put pressure on the supply chain of critical medications and in cases resulted in interruptions/discontinuation of critical drugs
- The clinical development of new investigational products has been affected by the emergence of nitrosamines in Rifampin, a key clinical index drug employed in drug-drug interaction studies.
- Root cause, consequences and safety of MNP in Rafampin still uncertain for everyone
https://jpharmsci.org/article/S0022-3549(23)00019-9/fulltext
